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Cumulative experience of azimilide-associated torsades de pointes ventricular tachycardia in the 19 clinical studies comprising the azimilide database.

Publication ,  Journal Article
Pratt, CM; Al-Khalidi, HR; Brum, JM; Holroyde, MJ; Schwartz, PJ; Marcello, SR; Borggrefe, M; Dorian, P; Camm, AJ; Azimilide Trials Investigators,
Published in: J Am Coll Cardiol
August 1, 2006

OBJECTIVES: The purpose of this study was to assess the incidence, temporal characteristics, and risk factors associated with azimilide-associated torsades de pointes (TdP) ventricular tachycardia. BACKGROUND: Azimilide dihydrochloride is a class III antiarrhythmic drug possessing Ikr and Iks channel-blocking properties. METHODS: Oral azimilide (75 to 125 mg/day) was taken by 5,375 patients in 19 clinical trials conducted at 775 international centers. Of 3,964 patients in double-blind studies, 1,427 had a history of atrial fibrillation or other supraventricular arrhythmia, 510 had an implantable cardioverter-defibrillator, and 2,027 were post-myocardial infarction patients with a left ventricular ejection fraction < or =35%. RESULTS: The TdP occurred in 56 patients assigned to azimilide, was dose-related, and tended to occur earlier with an azimilide-loading regimen. Forty-three percent of TdP patients had a QT interval corrected by Bazett's formula, for heart rate, (QTc) > or =500 ms at the time of or before the TdP occurrence. Significant risk factors using logistic regression were increasing age, female gender, diuretic use, and lack of aspirin use. CONCLUSIONS: Azimilide-associated TdP has characteristics and risk factors similar to other Ikr blockers. However, there is a distinctive temporal profile. The TdP events are not concentrated in the first week. The azimilide-associated TdP rate is 1% (95% confidence interval 0.78 to 1.35) and is not increased in patients with low left ventricular ejection fraction, even in women.

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

August 1, 2006

Volume

48

Issue

3

Start / End Page

471 / 477

Location

United States

Related Subject Headings

  • Torsades de Pointes
  • Time Factors
  • Piperazines
  • Middle Aged
  • Male
  • Imidazolidines
  • Hydantoins
  • Humans
  • Female
  • Electrocardiography
 

Citation

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Pratt, C. M., Al-Khalidi, H. R., Brum, J. M., Holroyde, M. J., Schwartz, P. J., Marcello, S. R., … Azimilide Trials Investigators, . (2006). Cumulative experience of azimilide-associated torsades de pointes ventricular tachycardia in the 19 clinical studies comprising the azimilide database. J Am Coll Cardiol, 48(3), 471–477. https://doi.org/10.1016/j.jacc.2006.04.075
Pratt, Craig M., Hussein R. Al-Khalidi, Jose M. Brum, Michael J. Holroyde, Peter J. Schwartz, Stephen R. Marcello, Martin Borggrefe, Paul Dorian, A John Camm, and A John Azimilide Trials Investigators. “Cumulative experience of azimilide-associated torsades de pointes ventricular tachycardia in the 19 clinical studies comprising the azimilide database.J Am Coll Cardiol 48, no. 3 (August 1, 2006): 471–77. https://doi.org/10.1016/j.jacc.2006.04.075.
Pratt CM, Al-Khalidi HR, Brum JM, Holroyde MJ, Schwartz PJ, Marcello SR, et al. Cumulative experience of azimilide-associated torsades de pointes ventricular tachycardia in the 19 clinical studies comprising the azimilide database. J Am Coll Cardiol. 2006 Aug 1;48(3):471–7.
Pratt, Craig M., et al. “Cumulative experience of azimilide-associated torsades de pointes ventricular tachycardia in the 19 clinical studies comprising the azimilide database.J Am Coll Cardiol, vol. 48, no. 3, Aug. 2006, pp. 471–77. Pubmed, doi:10.1016/j.jacc.2006.04.075.
Pratt CM, Al-Khalidi HR, Brum JM, Holroyde MJ, Schwartz PJ, Marcello SR, Borggrefe M, Dorian P, Camm AJ, Azimilide Trials Investigators. Cumulative experience of azimilide-associated torsades de pointes ventricular tachycardia in the 19 clinical studies comprising the azimilide database. J Am Coll Cardiol. 2006 Aug 1;48(3):471–477.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

August 1, 2006

Volume

48

Issue

3

Start / End Page

471 / 477

Location

United States

Related Subject Headings

  • Torsades de Pointes
  • Time Factors
  • Piperazines
  • Middle Aged
  • Male
  • Imidazolidines
  • Hydantoins
  • Humans
  • Female
  • Electrocardiography